Glyburide

Product NDC
0143-9920
11-digit product format
001439920
Labeler code
0143
Product ID
0143-9920_2e1f1fed-bd3b-4cc5-92cc-17b78b5871cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA075890
Marketing category
ANDA
Marketing start
2003-08-01
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
6 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0143-9920DDiscontinued by firm2026-08-03
excluded packagepackage0143-99200143-9920-01DDiscontinued by firm2026-08-03
excluded packagepackage0143-99200143-9920-05DDiscontinued by firm2026-08-03
excluded packagepackage0143-99200143-9920-10DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-9920-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-9920-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-9920-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-9920-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-9920-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-9920-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-9920-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-9920-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-9920-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-9920-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-9920-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-9920-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-9920-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-9920-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-9920-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-9920-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-9920-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-9920-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-9920-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-9920-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-9920-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-9920-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-9920-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-9920-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-9920-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-9920-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-9920-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-9920-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-9920-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-9920-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-9920-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-9920-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-9920-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-9920-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-9920-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-9920-05557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075890-001GLYBURIDE (MICRONIZED)GLYBURIDE1.5MGTABLET / ORAL2003-07-31
A075890-002GLYBURIDE (MICRONIZED)GLYBURIDE3MGTABLET / ORAL2003-07-31
A075890-003GLYBURIDE (MICRONIZED)GLYBURIDE6MGTABLET / ORAL2003-07-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075890-002GLYBURIDE (MICRONIZED)3MGTABLET / ORAL2003-07-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075890-003GLYBURIDE (MICRONIZED)6MGTABLET / ORAL2003-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075890-001GLYBURIDE (MICRONIZED)1.5MGTABLET / ORAL2003-07-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075890-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075890-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075890-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075890-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075890-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075890-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075890-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075890-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075890-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075890-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075890-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075890-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075890-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075890-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075890-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075890-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075890-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075890-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075890-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075890-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075890-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075890-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075890-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075890-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075890-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075890-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075890-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075890-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075890-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075890-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075890-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075890-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075890-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075890-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075890-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075890-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075890-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075890-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075890-003AB1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075890-001AB1a72a2bbeb626…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9920-01EA - Each0143-9920cf6e8e5c-59b7-4d8f-95cf-4ea1a01e6af812012-07-24
0143-9920-05EA - Each0143-9920470fe7a0-1a45-4ec4-b90c-874e563d478b12012-07-24
0143-9920-10EA - Each0143-9920ecab0f28-3dac-4ada-84ef-8765551b947612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [WEST-WARD PHARMACEUTICALS CORP]11
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [WEST-WARD PHARMACEUTICALS CORP]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLYBURIDE TABLET [WEST-WARD PHARMACEUTICALS CORP]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [WEST-WARD PHARMACEUTICALS CORP]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLYBURIDE TABLET [WEST-WARD PHARMACEUTICALS CORP]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [WEST-WARD PHARMACEUTICALS CORP]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLYBURIDE TABLET [WEST-WARD PHARMACEUTICALS CORP]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLYBURIDE TABLET [WEST-WARD PHARMACEUTICALS CORP]11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9920-0100143992001100 TABLET in 1 BOTTLE, PLASTIC (0143-9920-01) 100 tablet2003-08-010000-00-00NoNoCurrent
0143-9920-0500143992005500 TABLET in 1 BOTTLE, PLASTIC (0143-9920-05) 500 tablet2003-08-010000-00-00NoNoCurrent
0143-9920-10001439920101000 TABLET in 1 BOTTLE, PLASTIC (0143-9920-10) 1000 tablet2003-08-010000-00-00NoNoCurrent